European Commission approves long-acting HIV drug option
Posted: 19 September 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The first long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition, has been approved in the European Union (EU).
The European Commission has authorised Apretude (cabotegravir long-acting (LA) injectable and tablets) for human immunodeficiency virus (HIV) prevention.
Cabotegravir LA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents (at least 12 years of age), weighing at least 35kg.
The approval provides the first and only prevention option authorised in the EU that reduces the number of doses needed for effectively preventing HIV, from 365 daily pills to as little as six injections annually.
ViiV Healthcare’s cabotegravir LA is the first and only long-acting injectable PrEP option proven superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in reducing HIV acquisition.
Due to the findings from the clinical trials, cabotegravir injectable and tablets for PrEP offers patients the EU more options for PrEP.
Data supporting EU approval of the long-acting HIV medicine
EC’s approval is supported by data from two international Phase IIb/III studies, HPTN 083 and HPTN 084. These trials evaluated the safety and efficacy of cabotegravir LA for PrEP in HIV-negative men who have sex with men (MSM), transgender women and cisgender women who were at increased risk of sexually acquired HIV.
Long-acting cabotegravir was found to be superior to daily oral FTC/TDF in preventing HIV acquisition in the trial populations. Participants experienced a 69 percent lower rate of acquisition compared to FTC/TDF tablets in HPTN 083. A 90 percent lower rate of acquisition compared to FTC/TDF tablets was observed in the HPTN 084 trial.
Cabotegravir LA for PrEP is approved for use as Apretude, in countries including the US, Australia, South Africa. Submission to other regulatory agencies is on-going, according to GSK.
“This authorisation marks a pivotal milestone for people across the EU who could benefit from an innovative, long-acting HIV prevention,” declared Deborah Waterhouse, CEO at ViiV Healthcare.
Generic manufacturers sign sublicences to produce long-acting HIV medicine
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